- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04970849
Survey Study About Endoscopy During COVID-19 Pandemic for IBD Doctors
July 19, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Patterns of Endoscopy During COVID-19 Pandemic: a Global Survey of Interventional Inflammatory Bowel Disease Practice
Performance of diagnostic or therapeutic endoscopic procedures in inflammatory bowel disease (IBD) patients can be challenging during a viral pandemic; the main concerns being the safety and protection of patients and health care providers (HCP).
The aim of this study is to identify endoscopic practice patterns and outcomes of IBD and coronavirus disease 19 (COVID-19) with a worldwide survey of HCP.
Study Overview
Detailed Description
The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn's and Colitis Foundation.
The data of the survey was collected and analyzed.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hangzhou
-
Zhengzhou, Hangzhou, China, 310000
- Second Affiliated Hospital Zhejiang University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The content of survey included: The number of procedures, the indication of endoscopy, the number of patients with IBD diagnosed Covid-19, and the influence of the epidemic situation on the diagnosis and treatment of IBD.
Description
Inclusion Criteria:
- Doctors who are involved in the endoscopic treatment of IBD patients;
- The endoscopist reads and signs an informed consent online. -
Exclusion Criteria:
- Doctors who are not involved in the endoscopic treatment of IBD patients
- Doctors who need the help of an agent, a witness, or someone else who can not complete the questionnaire independently.
- Other conditions that the researchers considered unsuitable for inclusion or influenced the participants'ability to complete the study.-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
one group that is IBD endoscopist who perform the endoscopy for IBD patients
Complete the questionnaire online
|
IBD doctors who perform the endoscopy perform the questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist
Time Frame: 1 week
|
The incidence of scheduled IBD endoscopies were postponed or cancelled due to the pandemic.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of COVID19 in IBD patients who underwent endoscopy
Time Frame: 1 week
|
The percentage of IBD patients who underwent endoscopy since the outbreak was tested positive for COVID 19
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yan Chen, 浙江大学医学院附属第二医院
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2021
Primary Completion (Actual)
July 15, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
July 15, 2021
First Submitted That Met QC Criteria
July 19, 2021
First Posted (Actual)
July 21, 2021
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 19, 2021
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- COVID-19
- Inflammatory Bowel Diseases
- Intestinal Diseases
Other Study ID Numbers
- I2020001357
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The result of questionnaire can be shared
IPD Sharing Time Frame
now is available
IPD Sharing Access Criteria
All the doctors
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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